Study Protocol for a Single-center Randomized Clinical Trial: Evaluating the Effectiveness of Combined Therapy versus Conventional Therapy Approaches to Improve Physical & Behavioral Status among Children with Autism Spectrum Disorder

Objective: Currently, traditional Autism Spectrum Disorder (ASD) treatments include occupational therapy and speech and language therapy (SLT), however, physiotherapy has little evidence of efficacy. Hence, this study aims to compare physiotherapy, occupational therapy as well as speech and language therapy as need-based interventions for ASD patients with physical and behavioral deficits. Material and Methods: An assessor and participant blinded randomized clinical trial (RCT) was designed for 70 cases diagnosed with ASD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM) V, from July 2024 to April 2025, with each being randomly assigned to either Group A or Group B. Participants of Group A will receive physiotherapy plus occupational therapy with SLT and group B will receive only occupational therapy plus speech and language therapy for 4 weeks. The outcome of this study will be physical status determined by modified SF-36 scores and behavioral status via GARS-3 scores. The study site will be Proyash (an Institute of Special Education), Jashore Area, Bangladesh. Study analysis will be conducted according to the nature of the data, and will include intention-to- treat analysis. Results: The results of this study are expected to determine that comprehensive multidisciplinary practices of ASD can advocate the benefits for children and adolescents with ASD, the parents, other stakeholders and special schools throughout Bangladesh.Conclusion: This study will address the research gap on the impact of the outcome of physiotherapy interventions, along with occupational therapy with SLT, on behavioral and physical status for the participants of ASD.